Medical devices, like other products, have both tangible and intangible attributes. These include how the product looks, how it feels during use, how well it functions, how much it costs, and how the customer obtains it. In skill-defined industries such as medicine, how a product is designed—and who designs it—can also be an attribute. A product designed by experts in the field enhances the user's perception of quality.

When designing a product, involving customers who are noted in the field can add further credibility to the product and can assist in driving its adoption. It is important to avoid going too far in the other direction, however. Designing with the help of highly skilled peer leaders can result in the development of tools that only real experts can use. A team whose membership represents a balanced cross section of intended end-users helps ensure broad adoption. This relates to both a product's feature set and its price point. In some cases, it can influence promotional method as well. Where price is concerned, for example, some user subsegments may possess greater buying power. Team members from those segments may desire a more-extensive, or more-expensive, feature set.

Customer-Expert Teams

When releasing products, companies routinely claim involvement of the customer in their design. In reality, however, participation in a design is often limited to casual involvement, such as a focus panel during some phase of the design. True customer-centric design requires a deeper level of customer involvement than focus panels provide. Customer-expert teams should be assembled early so that they participate in the part of the design process normally reserved for company employees. Such involvement allows thorough design input.

This article discusses the assembly and use of a customer-expert team that participates actively through all phases of product design. Such a team offers advice on desired feature sets, tests crude and production-level prototypes, and serves as product trainers if necessary once the project is complete.

Customer-expert teams are often confused with focus groups. Focus groups can be important at milestones during the design process. They are valuable in gauging initial reaction to concepts or prototypes. However, such groups are reserved for research aims and are arm's-length, typically anonymous, panels that do not participate in multiple phases of design.

By contrast, a customer expert on a team may be willing to continue on after the completion of the development project in an endorsement or advisory role. If the product embodies new technology or a new technique, such customer experts are the best candidates to train new users when the product is released.

In the medical-surgical market, product endorsers have typically been high-visibility persons who merely lend their name to a product. Salzman et al. theorize that skeptical customers require more than just arm's-length endorsement to confer quality and suitability to a product.1 For an endorsement to be relevant, the user group must have some sort of genuine attachment to the product's development.

Figure 1. (Click to enlarge) Different teams participate in various phases of development. Customer experts can be appointed to phase-specific groups depending on the project's requirements.

Involving a logically selected group of end-users in the design from start to finish is much less common than using customers in a way normally associated with experiential market research. In this model, customer experts do not run the project or dictate feature sets. They participate in early user research, attend meetings of the larger team along with representatives from marketing and research and development, and communicate routinely by phone, e-mail, and intranet. They essentially become an extension of the company (see Figure 1). A customer-expert team is analogous to a compass: they do not direct activity, but they do confirm whether a chosen direction is correct.

The Model in Practice

In one project, Gyrus ENT involved 32 customers directly and several dozen more as part of primary market research used to validate hypotheses about the project.

The project involved development of a device in a mature market segment with a dominant competitor, and it was unclear whether a new product entrant could be successful. Assessment of both the market and company indicated that the project required an expert team to ensure market acceptability.

The company engaged customers in every phase of design. Customers participated in seminal exploratory interviews, concept generation, crude prototyping, evaluation of shape explorations and functional prototypes, and finally, actual use of production-level prototypes.

Surgeons were involved in two traditional exploratory research exercises. A core group of six surgeons was selected to work elbow-to-elbow with the business and engineering team from start to finish. Three others joined in the latter stages of design for laboratory testing, and nine more assisted in clinical beta testing of production-level prototypes. Representatives from ancillary groups such as nursing and reprocessing were brought into the project when specific direction from that type of user was required. The customers participated in the redevelopment of what ultimately became the recipient of a gold IDEA Design Excellence Award for Design Exploration and a silver Medical Device Excellence Award.

A challenge for the project leader lies in getting the most design input possible from people whose professional expertise is not product design or development. The project leaders from the sponsor should conduct design exercises that encourage fresh thought and that help overcome preconceptions of what a given device should be. This is especially true when working on product improvements and on next generations of in-kind products. Examples of these methods are well documented in the design literature. Users become accustomed to the presence of certain features and inconveniences associated with a given type of device. It is up to the leader to find ways to break through barriers of preconceptions. Asking members of the group to describe their dream device without respect for its feasibility is one method for doing so.

Integrating Customers into the Inner Workings of Design

Candid assessment of a company's strengths must be done before a project can begin. Many companies must look outside to professional designers or individual contractors to fill the skill gaps. Customer experts can provide valuable information throughout the project, but other positions on the design team, such as human factors and engineering, must be filled with competent professionals in those fields.

Customer experts can provide insight and perspective. As part of the design and testing effort, customers develop a psychological and emotional bond to the end product. Future users of the product in turn tend to view the product more favorably because of their peers' involvement. Casual involvement in individual phases of development cannot create this deep attachment.

By contrast, ongoing advisory panels tend to lose their objectivity. The difference between an expert team and an advisory panel lies in the duration of their involvement. An advisory group that remains in place and is called upon for project after project can morph from a design team to an adjudicating body, passing judgment or rendering opinions rather than actively participating in development.

Customer experts can be assembled into teams that work closely with the traditional business disciplines, or they may participate less formally. In either case, these are not passive groups that serve as product review boards or focus panels. Customer experts review concepts, drawings, and prototypes. They attend design meetings and even participate in creative sessions for promotional materials.

Customer-expert design teams, as described here, function as an integral part of the larger design team along with the company and perhaps an outside design entity. These teams are participants in the design effort. They are not merely asked to endorse a product once it has already been designed.

The more integral a role customer experts play in the project, the more their affiliation can be associated with the product. Being able to genuinely claim meaningful design input from real customers creates a powerful message to the target market. The reputation of the team's membership can even serve to enhance the image of the product itself.

Because customer groups of this sort in essence work alongside the traditional business disciplines of R&D, marketing, production, regulatory, and sales, much depends on how these individuals are selected for the team.

Finding customers to participate in a design project rarely presents a problem. Customers frequently enjoy the mental stimulation and occasional notoriety that accompanies working on products. Finding the ones best suited for the task presents challenges, however.

Assembling a Customer Team

It is essential to develop a selection protocol that identifies individuals who can contribute to design projects and who work well together during all phases of a project. The same protocol can be applied to selection of candidates for the test-market team.

A multifaceted protocol begins by considering the market objective and how the customer team members will interact with each other and with the business team. (The business team may include an outside firm hired to fill in gaps in company expertise or to enhance the resource pool. This was true for the Gyrus project, where the company lacked human factors, electrical engineering, and software engineering disciplines.)

A protocol should include the following attributes for consideration:

• Market measures. These include notoriety, skill in use of the product, skill in the professional specialty and area of interest, and prior design team experience.
• Project suitability measures. These include team chemistry, availability and accessibility, geographic orientation, and team size.
• Other considerations. These can include legal aspects and timing considerations.

Developing the List. Exploratory research helps identify the influencers among the target market. Primary research should occur weeks before recording the list of possible expert-team members. Personal interviews work well for this purpose. Interviews do not necessarily need to be blinded, but good survey writing and interview techniques should be used to eliminate bias. Interviews should be conducted by individuals who most likely will not be part of the design team.

The research data should be carefully analyzed to select the initial list of names. That information should then be reviewed with the core design team members from the company and refined to a short list of final candidates.

Team membership should not be treated as a reward mechanism or an enticement to do additional business with the company. Involving users in attempts to turn them into paying customers is a mistake when assembling customer-expert teams. Depending on the arrangement, this can also be illegal.

Market Measures. Aaker defines branded energizers as product attributes, affiliated promotional material, or associations that enhance the perception of the target brand.2 Identifying a product with key opinion leaders validates the product. Both the customer expert, and the process itself, can be used as branded energizers. Even when the user design team is kept anonymous, customer-centric design resonates with future users by demonstrating the importance the company places on involving its customers. Beyond just name reference, describing the process in sufficient detail can give the prospect additional confidence in the product's suitability.

Perception of quality and expert design help fuel a positive reception for a product. Customer involvement in the design of a product adds a dimension that is much more powerful than an endorsement by an uninvolved personality, even if that person is an expert in the field.

Two aspects of customer-centric design are key to how it will affect the marketing effort: the reputation of the customer experts and the description of the process itself.

A customer-centric approach to product development, when used as a product attribute, can serve as a proxy for user reference. Early adopters routinely purchase products without the benefit of references from others who have tried or purchased the product. The early adopter group makes up only a small percentage of total users. Followers, or customers outside the early adopter group, rely on references to help shape their buying decision. They look to the icons and their early-adopter peers for product advice. Some also await supportive clinical evidence.

Endorser Notoriety

It's not uncommon to hear customer prospects ask, “Who worked on this product?” It is assumed by the market that companies somehow involve customers during product design, however casual or brief the involvement. A company that wants the market to strongly perceive the customer-centricity of its product should clearly define the relevance of its customer-expert team. How candidates are measured for this criterion depends on how much the product will be associated with the design team once the product is released. It is critical to determine whether it is important for the product to be associated with names in the business, or whether it is merely important that the product be known to have involved a number of customer experts in its design.

Solitary Designer Endorser. Some products are usually associated with pioneers in a field, also called icons. These are specialists who are instantly associated with an area of expertise. In the medical-surgical area, products sometimes begin as custom-manufactured items, then gain popularity from the strong name association with a single iconic designer or from a designer who publicizes the device or a related technique.

Products associated with a single person require that the name be recognized universally as an innovator or icon in the specialty, without negative associations. Companies that are lesser known in a product segment find that publicizing strong associations with clear leaders in the field helps endow immediate credibility.

In this scenario, the association with the experts can serve as a proxy for product suitability and quality. A prospective user tends to prejudge the product as excellent based upon the association with the iconic designer. The product must, of course, deliver on the perception. The onus for quality and relevance still clearly falls to the company.

Designer-Endorser Teams. In this model, the design team comprises thought leaders in a particular specialty. The design team members are well known, although they may not be icons.

Single team members have a particular area of expertise or interest within the larger specialty that makes them suited to contribute in a specific area of the project. Each designer endorser's involvement, when promoted, adds credibility to the finished product by virtue of that person having been intimately involved.

In a truly collaborative environment, no one member develops an unhealthy attachment to his or her own ideas. It is natural to have strength of conviction, but the overriding goal should be the final product. Ideas from each member become ingredients in the final product. All of this underscores the necessity of carefully screening team candidates before inviting them to participate.

Anonymous Teams. In this model, the names of customer experts may never be released publicly. When the company is building upon an established, strong brand, known endorsers or designers are less important. Describing a customer-centric design process can be enough. When the product or brand is strong, its appeal may be enhanced by giving it an everyman association.

Skill in Product Use

Power users are natural candidates for membership on the customer-expert team. Unless the project focus is more on research than on creating a product upgrade or a next-generation product, skill in the use of similar products should be considered. If the end product will function similar to, or replace, an existing technology, assessing a person's skill in the use of that product type becomes important. Highly skilled users may include faculty members in teaching centers or those involved in professional symposia. A review of brochures from society meetings and continuing medical education courses can help a company assess the skills of potential team members.

The product being developed may ultimately be targeted only for users of exceptional skill or for very specific uses. Customers who are highly skilled in the use of similar products may be less particular about product features than lesser-skilled users. It is wise to balance the team with users who are representative of the average user along with those having more substantial expertise. Expert users can often compensate for user-unfriendly features and may not feel strongly enough to object publicly during design exercises.

Skill in a Focus Area

Specialties frequently segment into subspecialties. Some users might have expertise in a subspecialty but not work solely in that area. Consider whether an expert's work is so specialized that its applicability may be limited.

The team should have representation from all relevant users. The Gyrus project, for example, was designed to be used by several types of ENT specialists, so it made sense to include laryngologists, general ENTs, and rhinologists as customer experts on the design team.

If a product such as a powered surgical device will be used and maintained by several different types of customers, all subgroups should be included in the design exploration. In the Gyrus example, surgeons in practice interacted with the powered surgical handpiece but were often unaware of the workings of the power generator, to which the circulating nurse must attend. So, circulating nurses were the better resource for user input concerning the power generator. Likewise, the reprocessing department could address the ease of cleaning and sterilization of the device and was consulted during the design exploration. It is easy to overlook these key constituencies when designing a product. Soliciting input from all user groups is important when considering variables that could stymie a product's success later.

Prior Design Team Experience

When measuring experience, customer experts fall into two basic categories: the user experts with design experience, and those without design experience but who are representative of the target market for the finished product. Either of these may or may not actually be customers of the company at the moment they are considered. In fact, there is benefit to engaging customer experts who currently purchase little or nothing from the company. This assumes that there is no built-in animosity toward the firm.

Knowledge of how projects unfold probably means candidates will be familiar with timelines, deadlines, and the routine path that development customarily follows. Such experts probably also have an interest in product design. Team members who understand the design process increase the product's probability of success.

Some users may have established themselves as product designers and may already be known in the industry as having contributed to multiple designs. Some may even have engineering or MBA degrees. Since they may have had experience in working with companies, they may also expect fee-for-service arrangements. Some medical professionals have formed professional consortiums that work jointly on research and development projects.

Customer experts who have worked on similar projects may be in high demand by competitors. It is advisable to find subject-matter experts who have either been overlooked by competitors or have previously refused to work with those competitors.

The drawbacks to customer experts with previous design experience may not be obvious. For example, their ideas may not be novel and may have been incorporated into other devices in the competitive set. Though well intentioned, these experts can emerge as informal leaders during the project. Such team members may dominate discussions, perhaps inhibiting less-experienced team members. They may also come with ready-made demands for compensation, complicating the formation of the team.

In their most advanced form, the customers with design experience are those that are inventors. Although successful device companies have been launched by product designers, a self-styled inventor may be the least well suited to participate on a design team. Because good design comes from thorough user and experiential research, the customer inventor frequently proposes complete product solutions prematurely. Too often, an attempt is made to skip from the design problem directly to the answer and to contribute solutions rather than articulating needs or sharing product experiences.

Valuable customer experts clearly state features or product characteristics they like and dislike, even in unrelated products. They might say something basic such as, “A prism-shaped grip is very comfortable for me. My favorite pen has that kind of three-sided grip.” They share critical events or single occurrences that shape product loyalty for better or worse. Few truly winning ideas emanate from a single intellect. There are always exceptions, and the exception here is the single designer who has spent time in discussions with colleagues and listened to their product likes, frustrations, and expressions of desired features.

Conducting brainstorming exercises using methods tailored to encourage creativity can infuse fresh perspectives and assist nondesigners in thinking about the design problem in new ways. In one project, the original, crude prototype for what was ultimately the final design was made from miscellaneous objects found around the office. Kelley described this process in his book on innovation.3

Novices to the Design Process

The advantage of users with no previous design experience is the freshness of the perspective they can add. They approach the work unencumbered by preconception.

Novice customer experts are not always younger, less-tenured professionals, but they can be. Resident physicians can make terrific design team participants. Customers who are novices to design can benefit the development effort in other ways than design input. They can be sought for early design exploration or user research and later in the project for alpha or beta testing.

Project Suitability Measures

Team Chemistry. For a group to work, it must be made up of team players. How the team members interact with each other and with the company influences how well the design effort goes. It also influences the team's ability to meet deadlines. Team members who bicker unduly may cause the loss of precious time in the development cycle.

The personalities of candidate experts influence how well they may gel with the rest of the team. This is true especially in industries or product segments where key constituencies are well known. If experts are giants in their field, their input can eclipse that from other members of the team, even when that effect is unintended. Less-renowned team members may defer to uber-users out of reflex.

Availability and Accessibility. Membership on a design team is time-consuming. The customer experts should be expected to commit reasonable time to the project. The willingness to be available for meetings with reasonable notice influences how closely deadlines can be met. The team members should be willing to take time every weekday to return calls or e-mails and to spend adequate time reviewing drawings and prototypes.

It is important to set specific dates that the team will physically meet. Picking milestone dates that coincide with professional conferences most of the team will attend anyway can help ensure attendance.

Geographic Orientation. The geographic orientation of a group depends on the specialty. It can be helpful to include representation from other countries if the product will be used outside the United States. Geography can also be used as a consideration when attempting to decide between two equally qualified candidates.

Team Size. The number of members on a design team influences the amount of input provided and how easily group meetings can be held. The more members on the core team, the more input. And the more input, the better the wealth of information made available. But larger teams are more difficult to manage than smaller ones. Coordinating schedules and meeting planning becomes more complicated as the size of the group grows. More opportunity for conflict exists as well.

Legal Aspects. If the team will be compensated, legal counsel should be consulted to help structure the arrangements. All consulting and professional services arrangements require review by competent counsel. Legal counsel, whether internal or external, can construct appropriate agreements with the team considering all applicable law, particularly the Stark Act and antikickback laws and regulations.

Confidentiality agreements are absolutely essential when the project is more one of research without a defined market release date or when the project is blacked out (developed in as much secrecy as possible). Even if the project is for otherwise-routine upgrades, confidentiality or nondisclosure agreements are important documents to have in place.

Timing Considerations. Customer experts can be appointed to phase-specific groups, participating in development at various points during the process. Customers can be used in three discrete phases:

Each phase can have its own distinct group of customer experts. Their level of involvement, as well as the number of members that each phase requires, can vary.

Because the exploratory phase includes conventional methods of market research, it should, by nature, include more participants. By contrast, the core design team is required to work closely with the company. This involves attendance at meetings, consistent communication, and quick decision making. Therefore, fewer members can be a part of the core team. The test phase involves less centralization and requires a fresh perspective to evaluate the resulting products. The core team can be a part of this group, but the test group must necessarily have more members outside the core team for adequate sampling.

How to Invite an Expert Team

Smart people are attracted by projects that are intellectually stimulating. Further, emotional and psychological involvement in the project introduces a mission to the work, and having a mission intensifies the passion with which the team approaches the project. The belief that the project will indeed improve life makes it more engaging.

Projects that compel are ones that seek to be truly innovative and whose goal is to develop a product that offers real improvements, not merely incremental x + 1 or x + 2 advances. Incremental advances, sometimes called feature creep, are usually born of projects aimed at catching up to the innovator in the competitive set. The innovator introduces a paradigm-changing device, and the follower then attempts to copy the features that resonate with customers.

When a project is compelling, the product that is ultimately released to market will usually provide benefits to its users. And, at the close of the project—if it was a success—the customer experts will likely ask, “When can we do that again?”

The following is an effective method for inviting customers to participate on a customer-expert team.

• Approach each candidate for membership individually.
• Have confidentiality and nondisclosure documentation in place.
• Send written information that clearly conveys key elements of the project.
• Allow sufficient time for each candidate to review the materials.
• Follow up with a phone call to gauge interest.
• Schedule and make a personal visit if a candidate is interested. If the project is broad in scope or magnitude, a member of senior management should be present for meetings with prospects.

Conclusion

Assembling and using a customer-expert team can help ensure a product's market success. It is essential that this team participate actively through all phases of product design. When designing a product, involving customers who are noted in the field can add further credibility to the product and can assist in driving its adoption.

It is possible to design products that function well and that enjoy widespread adoption without the active involvement of a single end-user. Companies that are already market leaders with entrenched specialty product lines stand a better chance of getting by without user-centric design approaches than do their less-dominant competitors. Clearly, though, to establish a credible position of customer involvement and customer centricity, end-users must be included in at least some phase of product research or design. Deep and integral involvement of an intelligently assembled design team that includes credible members of the user community goes a long way toward ensuring success.